Status:
UNKNOWN
Paclitaxel-Carboplatin Alone or With M2ES for Non-Small-Cell Lung Cancer
Lead Sponsor:
Protgen Ltd
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A phase II, multicenter, randomized, double-blind, placebo-controlled study was carried out. Patients were randomly assigned to the treatment (PC + pegylated endostatin) or the control group (PC+ plac...
Detailed Description
A randomized phase 2 study, involving patients with advanced non-small-cell lung cancer who had not previously received chemotherapy, compared paclitaxel and carboplatin Plus placebo with paclitaxel a...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed, newly diagnosed stage IIIB or stage IV cancer or recurrent non-small-cell lung cancer for which they had not received chemotherapy, targeted therapy.
- Prior radiation therapy was allowed provided that the only sites disease were not located in lung.
- Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
- ≥18 years of age.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Adequate hematologic, hepatic, and renal function.
- Patients are voluntary to participate and sigh the informed contents.
Exclusion
- Major surgery within the prior 4 weeks.
- Participating any clinical trial within the prior 4 weeks.
- Patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
- Another active malignancy, or any history of other malignancy within the past 3 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix.
- Pregnant or lactating women.
- Radiation therapy have not been completed 4 weeks before enrollment.
- Pulmonary embolus, deep venous thrombosis or bleeding diathesis.
- Uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 12 months; Uncontrolled arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled infection.
- Grade 2 hemoptysis within the past 6 months.
- Acute or chronic renal disease.
- Active hepatitis or HIV.
- ECG: QTC ≥ 480 ms.
- Patients on therapeutic doses of heparin.
- Other conditions that are regarded for exclusion by the investigator.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01527864
Start Date
May 1 2011
End Date
April 1 2013
Last Update
February 7 2012
Active Locations (1)
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1
Cancer hospital, Chinese academy of medical science
Beijing, Beijing Municipality, China, 100021